Epigenomics AG is a molecular diagnostics company headquartered in

Berlin Berlin is Capital of Germany, the capital and largest city of Germany, both by area and List of cities in Germany by population, by population. Its more than 3.85 million inhabitants make it the European Union's List of cities in the European U ...

, Germany with a wholly owned subsidiary, Epigenomics Inc. based in

Seattle, WA Seattle ( ) is a seaport city on the West Coast of the United States. It is the seat of King County, Washington. With a 2020 population of 737,015, it is the largest city in both the state of Washington and the Pacific Northwest region of ...

History

Epigenomics was founded in

, Germany in 1998 by serial entrepreneur Dr Alexander Olek. Around the same time, ORCA Biosciences was founded in

. The companies merged in 2000, and have focused on applying DNA methylation based biomarkers to address medical needs. Epigenomics became a publicly traded company with its listing on the Frankfurt Exchange in 2004 raising €41.6 million. The company maintains a work force in Berlin, as well as in Seattle.

Focus

Epigenomics is focused on developing and marketing molecular diagnostics for oncology. The company has discovered

DNA methylation DNA methylation is a biological process by which methyl groups are added to the DNA molecule. Methylation can change the activity of a DNA segment without changing the sequence. When located in a gene promoter, DNA methylation typically acts ...

based biomarkers for a number of oncology related indications, has developed enabling technologies for the analysis of methylation in blood and other body fluids, and is bringing medically important products to the market. Key contributions to biomarker science based on DNA methylation include:

SEPT9 Septin-9 is a protein that in humans is encoded by the ''SEPT9'' gene. Interactions SEPT9 has been shown to interact with SEPT2 and SEPT7. Function Along with AHNAK, eIF4E and S100A11, SEPT9 has been shown to be essential for pseudopod ...

- Measurement in blood for detection of colon cancer.

SHOX2 Short-stature homeobox 2, also known as homeobox protein Og12X or paired-related homeobox protein SHOT, is a protein that in humans is encoded by the ''SHOX2'' gene. Function SHOX2 is a member of the homeobox family of genes that encode protei ...

- Measurement in lung fluid to aid in diagnosis of lung cancer.

PITX2 Paired-like homeodomain transcription factor 2 also known as pituitary homeobox 2 is a protein that in humans is encoded by the ''PITX2'' gene. Function This gene encodes a member of the RIEG/PITX homeobox family, which is in the bicoid class ...

- Measurement in prostate tissue as a prognosis factor for prostate cancer. The company continues to focus on discovering and validating DNA methylation based biomarkers, and developing the technology to make DNA methylation testing a routine practice in the clinical laboratory. Where possible, the results of these efforts are shared with the scientific community, as evidenced by >60 peer reviewed scientific publications over the past 10 years.

Products

Epigenomics has developed and launched two CE marked IVD products based on methylation biomarkers: * Epi ''pro''Colon - a test to measure the methylation status of the

promoter in plasma as an aid in early detection of colon cancer. * Epi ''pro''Lung - a test to measure the methylation status of the

gene in bronchial lavage fluid, to help in the workup of patients suspect to have lung cancer. These products are not currently available in the U.S. Epigenomics has licensed the

biomarker and certain DNA methylation technologies to

Quest Diagnostics Quest Diagnostics is an American clinical laboratory. A Fortune 500 company, Quest operates in the United States, Puerto Rico, Mexico, and Brazil. Quest also maintains collaborative agreements with various hospitals and clinics across the glob ...

and

ARUP Laboratories Associated Regional and University Pathologists, Inc. (ARUP Laboratories) is a Salt Lake City, Utah-based nonprofit laboratory at University of Utah's Department of Pathology. It is located in the University of Utah Research Park The University ...

in the US, as well as Warnex Laboratories in Canada. These labs have independently launched Laboratory Developed Tests for the SEPT9 biomarker, and are providing this SEPT9 testing service to the medical community in the US and Canada. Although these tests were developed independently by the licensees and Epigenomics therefore cannot guarantee their performance, the results of clinical validations by these companies are very similar to those obtained by Epigenomics. Epigenomics also has a strategic partnership with Abbott Molecular for the development of an IVD test kit based on the SEPT9 biomarker. Abbott has launched this test as a CE marked IVD in Europe under the brand name mS9.

References

Additional Publications

* {{authority control Biotechnology companies of Germany Companies based in Berlin Biotechnology companies established in 1998 1998 establishments in Germany Companies listed on the Frankfurt Stock Exchange